BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 4182409 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19944
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7434A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # V003407, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. SOLID GREEN LIGHT APPEARED BY THE 9 VOLT BATTERY ICON AFTER PRESSING STIMULATION ON BUTTON. THE PATIENT DID THE LIGHT TESTING WITH THE ¿NEW¿ BATTERY AND NO LIGHTS APPEARED. THE PATIENT TRIED A NEW BATTERY AND DID A LIGHT TEST AND ALL OF THE LIGHTS FLASHED. THE PATIENT TRIED THE IMPLANTABLE NEUROSTIMULATOR (INS) ON BUTTON AGAIN AND ONLY SAW A SOLID GREEN LIGHT NEXT TO THE 9 VOLT BATTERY ICON. THE PATIENT REPORTED NO STIMULATION SENSATION THAT STARTED AT 7 AM ON THE MORNING OF REPORT AT WHICH TIME THE PATIENT HAD A RETURN OF PAIN IN NECK AND SHOULDERS. THE REPORTER WAS NOT ABLE TO GET THE INS TURNED BACK ON. THE PATIENT PROGRAMMER APPEARED TO BE FUNCTIONING AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662143 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR